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    Clinical Trial Results:
    A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

    Summary
    EudraCT number
    		 2020-000842-32
    Trial protocol
    		 DE   ES   FR   IT   NL   GB   SE  
    Global end of trial date
    26 Jun 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Feb 2021
    First version publication date
    31 Dec 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Updated adverse events reporting description in the Adverse Events section.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-540-5774
    Additional study identifiers
    ISRCTN number
    		 ISRCTN85762140
    US NCT number
    		 NCT04292730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 37
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Singapore: 32
    Country: Number of subjects enrolled
    United States: 593
    Country: Number of subjects enrolled
    Spain: 144
    Country: Number of subjects enrolled
    Italy: 134
    Country: Number of subjects enrolled
    United Kingdom: 64
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Hong Kong: 28
    Country: Number of subjects enrolled
    Switzerland: 19
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Japan: 4
    Country: Number of subjects enrolled
    Sweden: 3
    Worldwide total number of subjects
    1113
    EEA total number of subjects
    394
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    788
    From 65 to 84 years
    295
    85 years and over
    25

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 15 March 2020. The last study visit occurred on 26 June 2020.

    Pre-assignment
    Screening details
    		 1138 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Remdesivir (RDV) for 5 Days
    Arm description
    		 Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    Other name
    GS-5734™, Veklury®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered on Day 1 followed by 100 mg on Days 2-5.

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Not mentioned
    Dosage and administration details
    Standard of Care treatment for COVID-19 infection was determined by the investigator and included various routes of administration and pharmaceutical forms.

    Arm title
    		 Part A: Remdesivir for 10 Days
    Arm description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    Other name
    GS-5734™, Veklury®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered on Day 1 followed by 100 mg on Days 2-10.

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Not mentioned
    Dosage and administration details
    Standard of Care treatment for COVID-19 infection was determined by the investigator and included various routes of administration and pharmaceutical forms.

    Arm title
    		 Part A: SOC Therapy
    Arm description
    		 Participants received continued SOC therapy.
    Arm type
    		 Standard of care

    Investigational medicinal product name
    Standard of Care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Not mentioned
    Dosage and administration details
    Standard of Care treatment for COVID-19 infection was determined by the investigator and included various routes of administration and pharmaceutical forms.

    Arm title
    		 Part B: Extension Treatment, Remdesivir for 10 Days
    Arm description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remdesivir
    Investigational medicinal product code
    Other name
    GS-5734™, Veklury®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered on Day 1 followed by 100 mg on Days 2-10.

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Not mentioned
    Dosage and administration details
    Standard of Care treatment for COVID-19 infection was determined by the investigator and included various routes of administration and pharmaceutical forms.

    Number of subjects in period 1 [1]
    		Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
    Started
    191
    193
    200
    503
    Completed
    179
    176
    178
    437
    Not completed
    12
    17
    22
    66
         Death
    2
    2
    4
    12
         Non-compliance with study drug
    -
    1
    -
    -
         Protocol Violation
    -
    -
    1
    -
         Lost to follow-up
    8
    12
    12
    48
         Withdrew consent
    2
    2
    5
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 26 participants (8 from 'Remdesivir for 5 days' group, 4 from 'Remdesivir for 10 days' group, 14 from 'Extension treatment-Remdesivir for 10 days' group) who were randomized but did not receive the study drug are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: Remdesivir (RDV) for 5 Days
    Reporting group description
    		 Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.

    Reporting group title
    Part A: Remdesivir for 10 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.

    Reporting group title
    Part A: SOC Therapy
    Reporting group description
    		 Participants received continued SOC therapy.

    Reporting group title
    Part B: Extension Treatment, Remdesivir for 10 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.

    Reporting group values
    		 Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days Total
    Number of subjects
    		 191 193 200 503 1087
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56 ( 14.6 ) 55 ( 15.5 ) 55 ( 15.1 ) 55 ( 16.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 77 75 75 221 448
        Male
    		 114 118 125 282 639
    Race
    Not Permitted = local regulators did not allow collection of race information.
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 1 3 6
        Asian
    		 34 31 37 61 163
        Black
    		 35 37 27 107 206
        Native Hawaiian or Pacific Islander
    		 1 1 1 1 4
        White
    		 109 107 112 260 588
        Not Permitted
    		 5 5 7 21 38
        Other
    		 5 12 15 50 82
    Ethnicity
    Not Permitted = local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    		 25 42 34 156 257
        Not Hispanic or Latino
    		 162 144 152 325 783
        Not Permitted
    		 4 7 13 22 46
        Missing
    		 0 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Part A: Remdesivir (RDV) for 5 Days
    Reporting group description
    		 Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.

    Reporting group title
    Part A: Remdesivir for 10 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.

    Reporting group title
    Part A: SOC Therapy
    Reporting group description
    		 Participants received continued SOC therapy.

    Reporting group title
    Part B: Extension Treatment, Remdesivir for 10 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.

    Primary: Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11

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    End point title
    		 Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 [1]
    End point description
    Clinical status was derived from death, hospital discharge, and ordinal scale as follows: 1 for all days on/after death date; 7 for all days on/after discharged alive date; last assessment for missing value. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration; 7. Not hospitalized. Full Analysis Set (FAS) included all participants who were randomized into Part A of the study and received at least 1 dose of study treatment (RDV groups) or had protocol Day 1 visit (SOC arm).
    End point type
    Primary
    End point timeframe
    Day 11
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was not analyzed for 'Part B: Extension Treatment, Remdesivir for 10 Days'.
    End point values
    		 Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy
    Number of subjects analysed
    191
    193
    200
    Units: percentage of participants
    number (not applicable)
        Score: 1
    0.0
    1.0
    2.0
        Score: 2
    0.0
    0.5
    2.0
        Score: 3
    2.6
    0.0
    3.5
        Score: 4
    3.7
    6.2
    5.5
        Score: 5
    19.9
    22.8
    23.0
        Score: 6
    3.7
    4.7
    4.0
        Score: 7
    70.2
    64.8
    60.0
    Statistical analysis title
    		 Part A: RDV for 5 Days vs Part A: SOC Therapy
    Statistical analysis description
    Primary analysis; The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.
    Comparison groups
    Part A: Remdesivir (RDV) for 5 Days v Part A: SOC Therapy
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0174 [2]
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.092
         upper limit
    		 2.483
    Notes
    [2] - P-value was calculated using proportional odds model with treatment as the independent variable.
    Statistical analysis title
    		 Part A: RDV for 10 Days vs Part A: SOC Therapy
    Statistical analysis description
    Primary analysis; The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.
    Comparison groups
    Part A: Remdesivir for 10 Days v Part A: SOC Therapy
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1826 [3]
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.952
    Notes
    [3] - P-value was calculated using proportional odds model with treatment as the independent variable.
    Statistical analysis title
    		 Part A: RDV for 5 Days vs Part A: SOC Therapy
    Statistical analysis description
    Secondary analysis; The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.
    Comparison groups
    Part A: Remdesivir (RDV) for 5 Days v Part A: SOC Therapy
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0168 [4]
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.095
         upper limit
    		 2.497
    Notes
    [4] - P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.
    Statistical analysis title
    		 Part A: RDV for 10 Days vs Part A: SOC Therapy
    Statistical analysis description
    Secondary analysis; The odds ratio represents the odds of improvement in the ordinal scale for a RDV group relative to the SOC group.
    Comparison groups
    Part A: Remdesivir for 10 Days v Part A: SOC Therapy
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2186 [5]
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.862
         upper limit
    		 1.917
    Notes
    [5] - P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.

    Secondary: Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) [6]
    End point description
    TEAEs were defined as the following: any AE with an onset date on or after the study treatment start date and no later than 30 days after permanent discontinuation of study treatment and/or any AE leading to premature discontinuation of study treatment. For participants randomized to the SOC group, all AEs reported on or after the protocol-specified Day 1 visit were considered as treatment emergent. Safety Analysis Set (SAS) included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group).
    End point type
    Secondary
    End point timeframe
    First dose date up to last dose date (maximum: 10 days) plus 30 days
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was not analyzed for 'Part B: Extension Treatment, Remdesivir for 10 Days'.
    End point values
    		 Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy
    Number of subjects analysed
    191
    193
    200
    Units: percentage of participants
        number (confidence interval 95%)
    51.3 (44.0 to 58.6)
    58.5 (51.3 to 65.6)
    46.5 (39.4 to 53.7)
    Statistical analysis title
    		 Part A: RDV for 5 Days, Part A: SOC Therapy
    Comparison groups
    Part A: Remdesivir (RDV) for 5 Days v Part A: SOC Therapy
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3633 [7]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in the Percentages
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 14.7
    Notes
    [7] - P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.
    Statistical analysis title
    		 Part A: RDV for 10 Days vs Part A: SOC Therapy
    Comparison groups
    Part A: Remdesivir for 10 Days v Part A: SOC Therapy
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0201 [8]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in the Percentages
    Point estimate
    12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 21.8
    Notes
    [8] - P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to the last dose date (maximum: 10 days for Part A, 11 days for Part B) plus 30 days.
    Adverse event reporting additional description
    Part A=Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment or completed the Day 1 visit (SOC only group); Part B=Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Part A: Remdesivir for 5 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5.

    Reporting group title
    Part A: Remdesivir for 10 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.

    Reporting group title
    Part A: SOC Therapy
    Reporting group description
    		 Participants received continued SOC therapy.

    Reporting group title
    Part B: Extension Treatment, Remdesivir for 10 Days
    Reporting group description
    		 Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.

    Serious adverse events
    		 Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 191 (4.71%)
    10 / 193 (5.18%)
    18 / 200 (9.00%)
    40 / 503 (7.95%)
         number of deaths (all causes)
    2
    3
    4
    13
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Cancer pain
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    General physical health deterioration
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Impaired healing
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    5 / 200 (2.50%)
    4 / 503 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Respiratory distress
         subjects affected / exposed
    0 / 191 (0.00%)
    2 / 193 (1.04%)
    2 / 200 (1.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    2 / 200 (1.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung opacity
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural bile leak
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    2 / 200 (1.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Corona virus infection
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    2 / 503 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 193 (0.52%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    1 / 200 (0.50%)
    0 / 503 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 193 (0.00%)
    0 / 200 (0.00%)
    1 / 503 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: Remdesivir for 5 Days Part A: Remdesivir for 10 Days Part A: SOC Therapy Part B: Extension Treatment, Remdesivir for 10 Days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 191 (21.47%)
    42 / 193 (21.76%)
    30 / 200 (15.00%)
    113 / 503 (22.47%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 191 (5.24%)
    10 / 193 (5.18%)
    5 / 200 (2.50%)
    27 / 503 (5.37%)
         occurrences all number
    10
    11
    5
    32
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    19 / 191 (9.95%)
    18 / 193 (9.33%)
    6 / 200 (3.00%)
    41 / 503 (8.15%)
         occurrences all number
    19
    18
    6
    42
    Diarrhoea
         subjects affected / exposed
    12 / 191 (6.28%)
    10 / 193 (5.18%)
    14 / 200 (7.00%)
    28 / 503 (5.57%)
         occurrences all number
    12
    10
    15
    29
    Constipation
         subjects affected / exposed
    8 / 191 (4.19%)
    5 / 193 (2.59%)
    9 / 200 (4.50%)
    26 / 503 (5.17%)
         occurrences all number
    8
    5
    9
    26
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    10 / 191 (5.24%)
    13 / 193 (6.74%)
    4 / 200 (2.00%)
    23 / 503 (4.57%)
         occurrences all number
    10
    13
    4
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2020
    Amendment 1: • Revised primary endpoint to allow for more robust analysis • Expanded number of sites and participants globally to meet urgent needs • Divided enrollment into 2 parts: A and B • Included an Extension Treatment Group during enrollment to extend RDV therapy (Part B) • Provided further clarification to the inclusion and exclusion criteria • Included parameters for adolescent participants and adolescent dosing • Revised statistical methodology and analysis due to changes in endpoints and study design • Clarified requirements for oxygen supplementation.
    29 Apr 2020
    Amendment 2: • Increased number of centers globally • Revised section on pediatric dosing with minor edits • Added language around discontinuation of study medication • Clarified exclusion criteria requirements • Clarified section on concomitant medications disallowed during study and revised concomitant medication assessment window • Added further guidance on pharmacokinetic (PK) assessments and sample collection timepoints • Added further guidance on virologic testing • Clarified assessment guidance for laboratory abnormalities • Revised sections on other endpoints of interest and planned analyses • Incorporated changes per the latest administrative amendment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32821939
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